Z-1328-2013Class II

Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12

Name: Z-1328-2013 Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12
Creator: Iris Diagnostics
Published: 2012-09-18
License: https://open.fda.gov/license/

International Remote Imaging Systems / initiated 2012-09-18 / Terminated / root cause: manufacturing process

FDA source

Iris Diagnostics began a recall of Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series on 2012-09-18. FDA classified it as Class II and gives the reason as "The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1328-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Posted: 2013-05-15
Terminated: 2014-01-27
Recalling firm: International Remote Imaging Systems
Product: Iris Diagnostics Division iQ Control/Focus Set, Part Number 800-3104, Lot Number 153-12. Product Usage: For in vitro diagnostic use with the iQ200 series.
Product code: JJW Urinalysis Controls (Assayed And Unassayed)
Reason for recall: The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below specification. This results in the instrument not passing controls and the customer not being able to run patient samples.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: IRIS sent a Medical Device Recall letter dated September 18, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to dispose of all unopened or partially used inventory, complete the attached worksheet certifying the disposal of the affected product and email or fax to Iris Diagnostics.
Quantity in commerce: 942 boxes
Distribution: Worldwide Distribution - USA Nationwide and the countries of: Canada, Malaysia, Spain, Switzerland, Taiwan, Peru, France, Russia, Japan, United Kingdom, Germany, and Paraguay.
Product codes and lots: Part Number 800-3104. Lot Number 153-12. Expiration date: Jan 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1328-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1328-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-22	2013-05-15

Product code JJW

K832713Class IIri Spec Urinalysis ControlIntl. Remote Imaging Systems / cleared 1983-12-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)